NCT00196482

Human Milk Fortifiers and Acid-Base Status

Impact of Human Milk Fortifiers on Acid-Base Status in Preterm Infants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 10 Days – 3 Months
• Healthy volunteers: Not accepted

Summary

Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants. Two different compositions are tested, main difference is in electrolyte composiiton.

Detailed description

Two groups each consisting of 15 infants with a birth weight below 2000g are studied.randomization is startified by three birth weigth classes (\<1000g, 1000-1500g,1500 - 2000g) human milk fortifier is introduced in two steps after oral feeding is achieved. two acid-base status and electrolyte concentrations are measured. when metabolic acidosis, defined as BE \< -6 mmol/l, occurs fortifier feeding is stopped, and after a wash-out period of three days the alternative product is used.again, occurence of metabolic acidosis, need for oral bicarbonate and effect on longitudinal growth an weight gain are registered.

Conditions

• Premature Birth

Interventions

Type	Name	Description
DRUG	changing of fortifier

Timeline

• Start date: 2004-06-01
• Completion: 2006-02-01
• First posted: 2005-09-20
• Last updated: 2006-09-12

Locations

1 site across 1 country: Germany